Juventas CAR-T Wins Second China Approval for Lymphoma, Expands Hematology Franchise
Juventas Cell Therapy Ltd. announced that inaticabtagene autoleucel (CNCT 19), China’s first self‑developed CD19‑targeting CAR‑T...
Drug
Innovent’s Picankibart Wins NMPA Approval for Psoriasis as IL-23p19 Inhibitor
Innovent Biologics, Inc. (HKG: 1801) announced that Picankibart Monoclonal Antibody Injection (IBI112), branded XINMEIYUE, received...
Boan Biotech’s Boyoujing Aflibercept Wins NMPA Approval for Retinal Diseases
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that its self‑developed Aflibercept Intravitreal Injection (Boyoujing)...
IASO-Bio’s Fucaso Wins Hong-Kong Approval as First China CAR-T
IASO Biotherapeutics announced that Fucaso (equecabtagene autoleucel injection), its proprietary fully human BCMA‑targeted CAR‑T cell...
BeOne’s Sotoclax Wins FDA Priority Review for Mantle Cell Lymphoma
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. FDA has accepted its...
Gene Key’s iNKT Cell Therapy Wins NMPA Nod for ARDS, First Allogeneic Ready-to-Use
Beijing Gene Key Life Technology Co., Ltd. announced that its GKL‑006RTU Injection, China’s first novel...
SciClone’s Meropenem-Vaborbactam Wins GBA Approval as First Antibiotic Under Medical Connect
SciClone Pharmaceuticals Inc. announced that Meropenem/Vaborbactam for Injection has been approved under the “Hong Kong-Macau...
Novartis’ Remibrutinib Wins NMPA Approval for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval...
Hengrui’s Three Oncology Assets Win NMPA Clinical Trial Approval
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that three of its investigational...
Humanwell’s Lisdexamfetamine NDA Accepted by NMPA for ADHD, First Generic Potential
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that the National Medical Products Administration (NMPA)...
Innovent’s mazdutide 9mg Obesity Application Accepted by NMPA
Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has accepted...
Fosun’s Luvometinib Gets NMPA Priority Review for Pediatric LCH
Fosun Pharma (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration (NMPA) has...
Otsuka’s VOYXACT Wins FDA Accelerated Approval for IgAN, First APRIL Blocker
Otsuka Pharmaceutical (OTCMKTS: OTSKY) announced that VOYXACT (sibeprenlimab‑szsi) received U.S. FDA Accelerated Approval for reducing...
Novartis’s Itvisma Wins FDA Approval as First Gene Therapy for SMA
Novartis AG (NYSE: NVS) announced that Itvisma (onasemnogene abeparvovec‑brve) received U.S. FDA approval for children...
Novo’s Kyinsu Wins EU Approval for Type 2 Diabetes, a Once-Weekly Combo First
Novo Nordisk A/S (NYSE: NVO) announced that the European Commission (EC) has granted marketing authorization...
Novo Nordisk’s Semaglutite Alzheimer’s Failure Sends Stock to 4-Year Low
Novo Nordisk A/S (NYSE: NVO) announced that semaglutide failed to slow disease progression in two...
Zelgen’s ZG006 Wins BTD for Neuroendocrine Carcinoma as First DLL3 Trispecific
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that ZG006, the world’s first trispecific antibody...
Hengrui’s Ivarmacitinib NDA Accepted for Non‑Radiographic Axial Spondyloarthritis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the China National Medical...